[Federal Register Volume 69, Number 103 (Thursday, May 27, 2004)]
[Rules and Regulations]
[Pages 30194-30199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11943]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
[Docket No. 1993P-0174]
Requirements for Liquid Medicated Animal Feed and Free-Choice
Medicated Animal Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is changing the
regulations for liquid medicated feed and free-choice medicated feed.
By changing the regulations for liquid medicated feed, FDA is
clarifying: What data are required to demonstrate chemical and physical
stability of a drug in liquid feed, how such data may be submitted for
use in the new animal drug approval process, and which liquid medicated
feeds may be manufactured in a feed manufacturing facility that has not
obtained a medicated feed mill license from FDA. By changing the
regulations for free-choice medicated feed, FDA is ensuring that they
are consistent with the requirements for liquid medicated feed, and
that provisions for free-choice medicated feed and liquid medicated
feed comply with the terms of the Animal Drug Availability Act (ADAA)
of 1996.
DATES: This rule is effective June 28, 2004.
FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 28, 2003 (68 FR 31645), FDA proposed
changing regulations for liquid medicated feed and free-choice
medicated feed and provided 90 days for comments on the proposed
changes.
Several events led to the development of the proposed rule. First,
an April 30, 1993, citizen petition requested that FDA amend Sec.
558.5 (21 CFR 558.5) to clarify the information and data needed to
demonstrate chemical and positional (physical) stability in liquid
medicated feeds and describe circumstances under which a medicated feed
application (MFA) will or will not be required. Second, our November
21, 1996 (61 FR 59209) advanced notice of proposed rulemaking, which we
issued seeking comments concerning various issues for the development
of regulations implementing provisions of ADAA, prompted the Animal
Feed Industry Association to propose changes to the new animal drug
requirements regarding free choice administration in feeds (Sec.
510.455 (21 CFR 510.455)).The proposed changes to Sec. 510.455 would
adopt the terms of feed mill licensing in accordance with ADAA and
allow a feed manufacturer to submit a new animal drug application
(NADA) for the approval of a Type A medicated article for use in the
subsequent manufacture of a free-choice medicated feed. This document
contains the liquid medicated feed and free-choice medicated feed final
rules.
II. Summary of the Proposed Rule
A. Liquid Medicated Feed
The proposed rule had the following objectives: (1) Replaced the
references to ``medicated feed application'' in the current rule with
the term ``medicated feed mill license,'' (2) defined the types of
liquid medicated feed covered by this regulation, (3) clarified the
types of approvals required for liquid medicated feed, (4) explained
that an approval is required for a drug intended for use in a liquid
feed and clarifies the procedures and requirements for demonstrating
chemical and physical stability of a drug in liquid feed, (5) permitted
submission of the stability data through a master file (MF) for
reference by a subsequent applicant, (6) explained what information
will be included in the published approval of a drug for use in liquid
feed, (7) identified the conditions under which an approved medicated
feed mill license will be required for the manufacture of a liquid
medicated feed, and (8) described the labeling provisions for several
drugs approved for use in water but not in liquid feed. We invited
comments on whether or not the waiver provision needs to continue to be
available because no one has invoked the provision since its inception
in 1973.
B. Free-Choice Medicated Feed
The proposed rule had the following objectives: (1) Modified the
current rule
[[Page 30195]]
by providing a definition of free-choice medicated feed, (2) explained
that one of three types of NADAs is required for a drug intended for
use in a free-choice feed, (3) specified the data required for such
applications and the procedures for their submission, (4) explained how
such data must be submitted, (5) stated what information will be
included in the published approval of a new animal drug intended for
use in free-choice feed, and (6) explained the situations that will
require a medicated feed mill license for the manufacture of a free-
choice medicated feed.
III. Comments on the Proposed Rule
We received three letters commenting on the proposed rule: Two from
trade associations and one from a feed manufacturer. The letters were
supportive of the proposed rule. Issues addressed in the comments
included waivers from labeling provisions, certified letters containing
proprietary information, and the free-choice and liquid feed stability
data requirements.
Following is our response to comments, grouped by issue:
A. Waiver From Labeling Provisions
(Comment 1) Two comments stated that the proposed rule should
retain the labeling provisions allowing a waiver of warning statements
on labels of dry medicated feeds containing bacitracin,
oxytetracycline, and/or chlortetracycline, as specified in Sec.
558.5(i). One of the two comments pointed out that the waiver option
should be retained because it provides needed information to liquid
feed manufacturers while granting appropriate labeling flexibility to
new animal drug applicants. The other comment indicated that although
the waiver has not been sought in the past, there are indications that
several firms are considering to request such a waiver in the future.
We agree with the two comments and are retaining the waiver option
in this final rule.
B. Providing a Certified Letter With the Formula and/or Specifications
of a Free-Choice or a Liquid Medicated Feed Product
(Comment 2) Two comments expressed concern about our intention,
expressed in the preamble of the proposed rule, to provide both the
NADA and the MF holder with a certified letter setting forth the
formula and/or specifications of a free-choice or a liquid medicated
feed product, where the formula and/or specifications are not published
in a regulation. The two comments argued that the certified letter,
which contains proprietary information, should only be issued to the MF
holder who owns that information, and not to the NADA holder.
We agree with these two comments and intend to provide a certified
letter only to the owner of the proprietary formula and/or
specifications, who is typically the MF holder.
(Comment 3) Two comments stated that currently there are many free-
choice and liquid medicated feed products approved through an MF for
which no such certified letters have been provided to the MF holders.
In order to avoid possible confusion at feed mill inspections, where
some products may have a certified letter and others may not, the two
comments stated that FDA should either issue such certified letters to
the MF holders of all such previously approved free-choice and liquid
medicated feeds, or make it clear in this rule that the certified
letter route applies only to free-choice and liquid feeds approved
after a certain date.
We intend to provide a certified letter to the owner of the
proprietary formula and/or specifications of those free-choice and
liquid medicated feed products that are approved after the effective
date of this rule. We do not intend to issue certified letters for feed
products approved before the effective date of this rule. Firms that
are making such feed products must be in compliance with existing
requirements and regulations pertaining to the manufacture of those
products.
C. The Free-Choice and Liquid Feed Stability Data Requirements
(Comment 4) Two comments stated that the agency should revisit the
stability data requirements as well as the consumption data and
manufacturing chemistry requirements articulated in the original April
30, 1993, citizen petition and revise the present liquid feed and free
choice feed guidances regarding these topics.
This comment falls outside of the scope of this rulemaking.
Comments pertaining to FDA guidance documents should be sent to the
dockets for those documents. More information on how to submit comments
to FDA guidance documents can be found at http://www.fda.gov/cvm/guidance/guidance.html#purpose.
IV. Final Rules
The final rules for liquid medicated feed and free-choice medicated
feeds adopt the proposed rules without change. For both the liquid
medicated feed and free-choice medicated feed final rules, FDA
concluded that an approved medicated feed mill license should be
required for facilities that manufacture free-choice or liquid
medicated feeds with proprietary formulas and/or specifications. Where
the formula and/or specifications are published, FDA has an assurance
that medicated feed mills have access to the information necessary to
manufacture the approved free-choice or liquid medicated feed. Where
the formula and/or specifications are proprietary, medicated feed mills
might attempt to manufacture the free choice or liquid medicated feed
knowing only that the drug is approved for use in free-choice or liquid
medicated feed, but not knowing the formula and/or specifications.
Manufacture of such feeds without this crucial information could
endanger animal health and public health. Section 510(h) of the act (21
U.S.C. 360(h)) requires that FDA inspect licensed medicated feed mills
at least once every 2 years. During such inspections, FDA can ensure
that medicated feed mills manufacturing free-choice or liquid medicated
feed with proprietary formulas and/or specifications have the approved
formula and/or specifications.
V. Environmental Impact
We have carefully considered the potential environmental impacts of
this rule and determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
This final rule merely clarifies existing regulations concerning
liquid medicated feeds and free-choice medicated feeds.
VI. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages, distributive impacts and equity). We believe that this
final rule is consistent with the regulatory philosophy and principles
identified in Executive Order 12866. We have also determined that the
rule is not a significant regulatory action as defined
[[Page 30196]]
by the Executive order and so is not subject to review under the
Executive order. Under the Regulatory Flexibility Act, if a regulation
has a significant impact on a substantial number of small entities, the
agency must analyze regulatory options that would minimize the impact
on small entities. FDA certifies in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612) that this rule will not have a
significant economic impact on a substantial number of small entities,
and therefore, a regulatory flexibility analysis is not required.
Section 202(a) of the Unfunded Mandates Reform Act requires that
agencies prepare a written statement of anticipated costs and benefits
before proposing any regulation that may result in an expenditure by
state, local and tribal governments in the aggregate, or by the private
sector, of $100 million or more (adjusted annually for inflation) in
any one year. The Unfunded Mandates Reform Act does not require FDA to
prepare a statement of costs and benefits for this final rule because
the rule is not expected to result in any 1 year expenditure that would
exceed $100 million adjusted for inflation. The current inflation-
adjusted statutory threshold is approximately $110 million.
The rule is intended to clarify, simplify, and elaborate on the
current regulations concerning liquid medicated feeds and free-choice
medicated feeds. This rule, which provides more precise and detailed
provisions than the previous regulations, responds to requests
submitted in citizen petitions and comments by an industry association.
It also makes changes to the regulatory language for free-choice
medicated feeds in order to be consistent with the ADAA provision that
replaced the medicated feed application system with the medicated feed
mill licensing system.
We did not receive any comments to the proposed rule that
questioned the conclusions of the cost and benefit discussions.
Further, changes made to the proposed rule as a result of other
comments would not affect these conclusions. As such, we restate them
for this final rule.
A. Liquid Medicated Feeds
The final rule for liquid medicated feeds clarifies the types of
liquid medicated feeds for which a separate new animal drug approval is
necessary and for which a medicated feed mill license is necessary. In
particular, it fully elaborates on the procedures and requirements for
demonstrating the chemical and physical stability of a drug in liquid
feeds, as well as how the data from such a demonstration can be
submitted to the agency.
The rule references requirements under 21 CFR 514.1 that are
currently required for the approval of all new animal drugs. As these
requirements do not represent a new burden, there is no cost associated
with this aspect of the rule. Likewise, the rule adds to the current
labeling provisions for certain drugs that are approved for use in
animal feed or drinking water but not approved for use in certain
liquid feeds. The rule describes the waiver process for the exclusion
of certain products from these labeling requirements. Because this
waiver process already exists under the current rule, it will not
impose any additional cost to industry.
B. Free-Choice Medicated Feed
The revisions to Sec. 510.455 concern free-choice medicated feed
and very closely follow the liquid medicated feed proposal. Section
510.455 clarifies and elaborates on the NADA requirements for drugs
intended for use in free-choice medicated feeds. In addition, it
replaces the language that provided for the medicated feed application
with language for the medicated feed mill licensing system that was
created by ADAA. Because the estimated costs and benefits of the feed
mill licensing system were prepared for the final regulations
implementing that system, these costs and benefits are not considered
to be effects of this rule. In total, the rule is not expected to
impose any new compliance burdens on the industry and is not associated
with any costs.
It is possible that the final rule will, in fact, result in some
cost savings due to the provision that eliminates the requirement for a
medicated feed mill license for the manufacture of some liquid and
free-choice medicated feeds that contain a Category I drug. In recent
years, we have received an average of 128 medicated feed mill license
applications annually. Since the applications do not explicitly specify
the types of medicated feed that would be manufactured, we are not able
to estimate the size of the decrease in applications that would be
expected as a result of the rule. However, we would expect there to be
some decrease in applications as some feed mills would be exempted from
this requirement in the future. We believe this could lead to a modest
cost savings for these feed mills. Further, the increased clarity and
simplification of Sec. Sec. 510.455 and 558.5 would be expected to
result in additional cost savings to industry in the preparation of new
animal drug applications to the agency. We cannot precisely quantify
such savings, but believe the impact to be modest.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the final rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VIII. Paperwork Reduction Act of 1995
In this final rule, Sec. 558.5 specifies procedures for obtaining
a waiver from labeling requirements for certain drugs intended for use
in animal feed or drinking water but not approved for use in liquid
medicated feed. The following items must be included in a request for
waiver: (1) A copy of the product label; (2) a description of the
formulation; and (3) information to establish that the physical,
chemical, or other properties of the product are such that diversion to
use in liquid medicated feeds is unlikely. This information would be
collected if the manufacturer or sponsor chose not to include the
required warning ``FOR USE IN --------ONLY, NOT FOR USE IN LIQUID
MEDICATED FEEDS'' on its product label. The sponsor or manufacturers
would then need to satisfy the requirements of the waiver section of
the regulation. The proposed burden estimate for this collection of
information is 5 hours and will be included under the clearance for
``New Animal Drug Application,'' Office of Management and Budget (OMB)
control number 0910-0032. All related data collections are already
covered under OMB control number 0910-0032.
IX. Conforming Changes
FDA has made conforming changes in its regulations in 21 CFR
558.95, 558.305, 558.311, 558.342, 558.355, and 558.625 to remove
references to the term ``medicated feed application.'' These conforming
changes ensure the accuracy and consistency of the regulations.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
[[Page 30197]]
Reporting and recordkeeping requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510 and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. Section 510.455 is revised to read as follows:
Sec. 510.455 Requirements for free-choice medicated feeds.
(a) What is free-choice medicated feed? For the purpose of this
part, free-choice medicated feed is medicated feed that is placed in
feeding or grazing areas and is not intended to be consumed fully at a
single feeding or to constitute the entire diet of the animal. Free-
choice feeds include, but are not limited to, medicated blocks
(agglomerated feed compressed or rendered into a solid mass and
cohesive enough to hold its form), mineral mixes, and liquid feed tank
supplements (``lick tank'' supplements) containing one or more new
animal drugs. The manufacture of medicated free-choice feeds is subject
to the current good manufacturing practice regulations in part 225 of
this chapter for medicated feeds.
(b) What types of approvals are required for new animal drugs
intended for use in free-choice feed? New animal drugs intended for use
in free-choice feed must be approved for such use under section 512 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)),
as:
(1) An original new animal drug application (NADA),
(2) A supplemental NADA, or
(3) An abbreviated NADA.
(c) What are the approval requirements for new animal drugs
intended for use in free-choice feed? (1) An approval under section 512
of the act is required for any new animal drug intended for use in a
free-choice feed.
(2) An approved NADA for a Type A medicated article intended for
use in free-choice feed must contain the following information:
(i) Data, or reference to data in a master file (MF), showing that
the target animal consumes the new animal drug in the Type C free-
choice feed in an amount that is safe and effective (consumption/
effectiveness data); and
(ii) Data, or reference to data in a MF, showing the relevant
ranges of conditions under which the drug will be chemically and
physically stable in the Type C free-choice feed under field
conditions.
(d) How are consumption/effectiveness and/or stability data to be
submitted? The data must be submitted as follows:
(1) Directly in the NADA, by a sponsor; and/or
(2) To an MF that a sponsor may then reference in its NADA with
written consent of the MF holder.
(e) What will be stated in the published approval for a new animal
drug intended for use in free-choice feed? The approval of a new animal
drug intended for use in free-choice feed, as published in this
subchapter, will include:
(1) The formula and/or specifications of the free-choice medicated
feed, where the owner of this information requests such publication, or
(2) A statement that the approval has been granted for a
proprietary formula and/or specifications.
(f) When is a medicated feed mill license required for the
manufacture of a free-choice medicated feed? An approved medicated feed
mill license is required for the manufacture of the following types of
feeds:
(1) All free-choice medicated feeds that contain a Category II
drug, and
(2) Free-choice medicated feeds that contain a Category I drug and
use a proprietary formula and/or specifications.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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4. Section 558.5 is revised to read as follows:
Sec. 558.5 Requirements for liquid medicated feed.
(a) What types of liquid medicated feeds are covered by this
section? This section covers the following types of liquid medicated
feed:
(1) Type B feed that is intended for further manufacture of other
medicated feeds (Sec. 558.3(b)(3)) or:
(2) Type C feed that is intended for the following:
(i) Further manufacture of another Type C feed, or
(ii) Top-dressing (adding on top of the usual ration) (Sec.
558.3(b)(4)).
(b) How is liquid free-choice medicated feed regulated? Liquid
free-choice medicated feed is covered by this section and by Sec.
510.455.
(c) What types of approvals are required for new animal drugs
intended for use in liquid feed? New animal drugs intended for use in
liquid feed must be approved for such use under section 512 of the act,
as:
(1) An original NADA,
(2) A supplemental NADA, or
(3) An abbreviated NADA.
(d) What are the approval requirements for new animal drugs
intended for use in liquid feed? (1) An approval under section 512 of
the act is required for any new animal drug intended for use in a
liquid feed; and
(2) An approved new animal drug application (NADA) for a drug
intended for use in liquid feed must contain the following information:
(i) Data, or a reference to data in a master file (MF), that shows
the relevant ranges of conditions under which the drug will be
chemically stable in liquid feed under field use conditions; and
(ii) Data, or a reference to data in an MF, that shows that the
drug is physically stable in liquid feed under field conditions; or
(iii) Feed labeling with recirculation or agitation directions as
follows:
(A) For liquid feeds stored in recirculating tank systems:
Recirculate immediately prior to use for not less than 10 minutes,
moving not less than 1 percent of the tank contents per minute from the
bottom of the tank to the top. Recirculate daily as described even when
not used.
(B) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than
10 minutes, creating a turbulence at the bottom of the tank that is
visible at the top. Agitate daily as described even when not used.
(e) How are chemical and physical stability data to be submitted?
The data must be submitted as follows:
(1) Directly in the NADA,
(2) By a sponsor, or
(3) To an MF that a sponsor may then reference in its NADA with
written consent of the MF holder.
(f) What will be stated in the published approval for a new animal
drug intended for use in liquid feed? The approval of a new animal drug
intended for use in liquid feed as published in this subchapter will
include the following requirements:
(1) The formula and/or specifications of the liquid medicated feed,
where the owner of this information requests such publication; and/or
(2) A statement that the approval has been granted for a
proprietary formula and/or specifications.
(g) When is a medicated feed mill license required for the
manufacture of
[[Page 30198]]
a liquid medicated feed? An approved medicated feed mill license is
required for the manufacture of the following types of feeds:
(1) All liquid medicated feeds that contain a Category II drug, and
(2) Liquid medicated feeds that contain a Category I drug and use a
proprietary formula and/or specifications.
(h) What measures are in place to prevent certain drugs, approved
for use in animal feed or drinking water but not in liquid medicated
feed, from being diverted to use in liquid feeds? Any product
containing any form of bacitracin, oxytetracycline, or
chlortetracycline, intended for oral administration via animal feed
and/or drinking water, and not approved for use in a liquid medicated
feed must include in its labeling the following statement: ``FOR USE IN
--------ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.'' The blank may be
filled in with the words: ``DRY FEEDS'', ``DRINKING WATER'', or ``DRY
FEEDS AND DRINKING WATER''.
(i) Can the labeling provisions of paragraph (h) of this section be
waived, and how can I apply for a waiver? (1) The labeling provisions
of paragraph (h) of this section may be waived if there is evidence to
indicate that it is unlikely a new animal drug would be used in the
manufacture of a liquid medicated feed.
(2) To obtain a waiver, you must submit a letter requesting a
waiver to the Office of New Animal Drug Evaluation (HFV-100), Center
for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855.
(3) The letter must include a copy of the product label; a
description of the formulation; and information to establish that the
physical, chemical, or other properties of the new animal drug are such
that diversion to use in liquid medicated feed is unlikely.
(j) What else do I need to know about the labeling provisions of
paragraph (h) of this section? The labeling provisions of paragraph (h)
of this section may be implemented without prior approval as provided
for in Sec. 514.8(d) and (e) of this chapter.
Sec. 558.95 [Amended]
0
5. Section 558.95 is amended in paragraph (d)(4)(iii)(d) by removing
the last sentence.
Sec. 558.305 [Amended]
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6. Section 558.305 is amended in paragraphs (d)(1)(i) and (d)(1)(ii) by
removing ``Type B'' wherever it appears.
0
7. Section 558.311 is amended by revising paragraph (d); in paragraph
(e)(2)(iv) by removing ``; each use of this Type C free-choice feed
must be the subject of an approved FD-1900 as provided in Sec. 510.455
of this chapter''; and in paragraph (e)(3)(iv) by removing the last
sentence to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(d) Special considerations. (1) Type C cattle and sheep feeds may
be manufactured from lasalocid liquid Type B feeds which have a pH of
4.0 to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid feeds stored in recirculating tank systems:
Recirculate immediately prior to use for no less than 10 minutes,
moving not less than 1 percent of the tank contents per minute from the
bottom of the tank to the top. Recirculate daily as described even when
not used.
(ii) For liquid feeds stored in mechanical, air, or other
agitation-type tank systems: Agitate immediately prior to use for not
less than 10 minutes, creating a turbulence at the bottom of the tank
that is visible at the top. Agitate daily as described even when not
used.
(2) A physically stable lasalocid liquid feed will not be subject
to the requirements for mixing directions prescribed in paragraph
(d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains
a suspending agent(s) sufficient to maintain a viscosity of not less
than 300 centipoises per second for 3 months.
(3) If a manufacturer is unable to meet the requirements of
paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure
approval of a positionally stable liquid feed by:
(i) Either filing a new animal drug application for the product or
establishing a master file containing data to support the stability of
its product;
(ii) Authorizing the agency to reference and rely upon the data in
the master file to support approval of a supplemental new animal drug
application to establish physical stability; and
(iii) Requesting the sponsor of an approved new animal drug
application to file a supplement to provide for use of its lasalocid
Type A article in the manufacture of the liquid feed specified in the
appropriate master file. If the data demonstrate the stability of the
liquid feed described in the master file, the supplemental new animal
drug application will be approved. The approval will provide a basis
for the individual liquid feed manufacturer to manufacture under a
medicated feed license the liquid mediated feed described in the master
file. A manufacturer who seeks to market a physically unstable
lasalocid liquid feed with mixing directions different from the
standard directions established in paragraph (d)(1) of this section may
also follow this procedure.
(4) If adequate information is submitted to show that a particular
liquid feed containing lasalocid is stable outside the pH of 4.0 to
8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of
this section may be waived.
* * * * *
Sec. 558.342 [Amended]
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8. Section 558.342 is amended in paragraphs (d)(1)(i) and (d)(1)(ii) by
removing the phrase ``Type B or C''; and in paragraph (d)(2) by
removing ``positionally'' and by adding in its place ``physically.''
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9. Section 558.355 is amended by adding paragraph (d)(12); and by
revising paragraphs (f)(3)(i)(b)(1), (f)(3)(i)(b)(2), (f)(3)(ix)(b),
(f)(6)(i)(b)(1), and (f)(6)(i)(b)(2) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(12) Mixing directions for liquid feeds requiring recirculation or
agitation:
(i) For liquid feeds stored in recirculating tank systems:
Recirculate immediately prior to use for not less than 10 minutes,
moving not less than 1 percent of the tank contents per minute from the
bottom of the tank to the top. Recirculate daily as described even when
not used.
(ii) For liquid feeds stored in mechanical, air, or other
agitation-type tank systems: Agitate immediately prior to use for not
less than 10 minutes, creating a turbulence at the bottom of the tank
that is visible at the top. Agitate daily as described even when not
used.
* * * * *
(f) Conditions of use. It is used as follows:
(3) Cattle--(i) Amount per ton. Monensin, 5-30 grams.
(b) Limitations. (1) Feed only to cattle being fed in confinement
for slaughter. Feed continuously in complete feed at a rate of 50 to
360 milligrams of monensin per head per day; as monensin sodium.
Complete feeds may be manufactured from monensin liquid Type B feeds.
The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must
bear appropriate mixing directions as defined in paragraph (d)(12) of
this section. The liquid feed must bear caution statement as follows:
Inadequate mixing, (recirculation or agitation), of liquid feeds has
resulted in increased
[[Page 30199]]
monensin concentration which has been fatal to cattle.
(2) An approved physically stable monensin liquid feed will not be
subject to the requirements for mixing directions defined in paragraph
(d)(12) of this section. A manufacturer may secure approval of a
physically stable liquid feed by:
(i) Either filing an NADA for the product or by establishing a
master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in
the master file to support approval of a supplemental NADA to establish
physical stability; and
(iii) Requesting No. 000986 in Sec. 510.600(c) of this chapter to
file a supplemental NADA to provide for the use of its monensin Type A
article in the manufacture of the liquid feed specified in the
appropriate master file. If the data demonstrate the stability of the
liquid feed described in the master file, the agency will approve the
supplemental NADA. The approval will provide a basis for the individual
liquid feed manufacturer to manufacture the liquid medicated feed under
a medicated feed mill license described in the master file. A
manufacturer who seeks to market a physically unstable monensin liquid
feed with mixing directions different from the standard established in
paragraph (d)(12) of this section may also follow this procedure.
* * * * *
(ix) Amount. * * *
* * * * *
(b) Limitations. Feed only to cattle being fed in confinement for
slaughter. Feed continuously at the rate of 8.2 to 10.2 kilograms (18
to 22.5 pounds) of Type C medicated feed per head per day to supply 240
milligrams of monensin and 90 milligrams of tylosin per head per day;
as monensin sodium; as tylosin phosphate. Do not allow horses or other
equines access to feeds containing monensin. Ingestion of monensin by
equines has been fatal. Safe use in unapproved species and breeding
cattle has not been established. The liquid medicated feed must bear
expiration date of 14 days after date of manufacture. The mixing
directions for this liquid medicated feed stored in recirculation or
agitation tank systems are as defined in paragraph (d)(12) of this
section.
* * * * *
(6) Goats--(i) Amount per ton. Monensin, 20 grams.
* * * * *
(b) Limitations. (1) Feed only to goats being fed in confinement.
Do not feed to lactating goats. Feed continuously in Type C feed as
monensin sodium. Type C feed may be manufactured from monensin liquid
Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their
labels must bear appropriate mixing directions, as defined in paragraph
(d)(12) of this section. The liquid feed must bear caution statement as
follows: Inadequate mixing, (recirculation or agitation), of liquid
feeds has resulted in increased monensin concentration which could be
fatal to goats.
(2) An approved physically stable monensin liquid feed will not be
subject to the requirements for mixing directions defined in paragraph
(d)12) of this section. A manufacturer may secure approval of a
physically stable liquid feed by:
(i) Either filing an NADA for the product or by establishing a
master file containing data to support the stability of its product;
(ii) Authorizing the agency to reference and rely upon the data in
the master file to support approval of a supplemental NADA to establish
physical stability; and
(iii) Requesting No. 000986 in Sec. 510.600(c) of this chapter to
file a supplemental NADA to provide for the use of its monensin Type A
article in the manufacture of the liquid feed specified in the
appropriate master file. If the data demonstrate the stability of the
liquid feed described in the master file, the agency will approve the
supplemental NADA. The approval will provide a basis for the individual
liquid feed manufacturer to manufacture the liquid medicated feed under
a medicated feed mill license described in the master file. A
manufacturer who seeks to market a physically unstable monensin liquid
feed with mixing directions different from the standard established in
paragraph (d)(12) of this section may also follow this procedure.
Sec. 558.625 [Amended]
0
10. Section 558.625 is amended in paragraphs (c)(1)(i) and (c)(1)(ii)
by removing ``Type B'' and by removing the phrase ``no fewer than 10
minutes'' and adding in its place the phrase ``not less than 10
minutes''.
Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11943 Filed 5-26-04; 8:45 am]
BILLING CODE 4160-01-S